Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04438369 |
| Other study ID # |
2018/2239 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
December 15, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Ostfold Hospital Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Ventral hernia repair is associated with significant postoperative pain, and regional
anesthetic techniques are of potential benefit.
The postoperative mobility and training is of utmost importance in this patient group, and
could be increased using local anesthetics instead of opioids.
Inadequate post-operative pain control can lead to adverse consequences for patients, such as
the development of chronic pain, immunosuppression, poorer healing of surgical wounds, as
well as adrenergic activation and its consequences in the form of coronary incidents or
gastrointestinal obstruction and postoperative nausea and vomiting (PONV). Moreover, lack of
mobility can result in thrombosis and embolism. These complications affect hospital
functioning, which leads to decreased patient satisfaction, a worse reputation for the
hospital, longer stays in the recovery room, prolonged hospitalizations, higher incidence of
re-surgeries and re-admissions, and higher costs for care and treatment.
Erector spinae plane block (ESPB) is the latest of the truncal blocks and was first described
in 2016. The efficacy of bilateral ESPB at the T7 level has been described in a study of 4
cases, moreover effective analgesia with ESPB after bariatric surgery has been described in a
study of 3 cases. When performed at the level of the T7 transverse process, studies show the
potential to block both supra-umbilical and infra-umbilical dermatomes. So far there are
mostly case studies done in this field of study, and internationally there is a call for
research into the effect of this technique and randomized controlled trials.
The objective of this study is to compare ESPB to multimodal analgesia in patients undergoing
ventral hernia repair.
Description:
Hypothesis, aims and objectives
The postulated nullhypothesis and alternativ hypothesis is:
H0= there is no difference in opioid consumption postoperatively between multimodal analgesia
and ESPB. HA= there is a reduction in opioid consumption postoperatively between standard
multimodal analgesia and ESPB.
Sample size calculation
Sample size estimation was calculated from our series of 20 pilot-patients on ventral hernia
surgery without block, who needed on average 24.6 mg oral morphine equivalents (OME) iv
oxycodone rescue analgesia during the first hour, SD=17.35 mg. Assuming a one sided study and
in order to show a 50% reduction in rescue opioid consumption after a successful block with
80% power and 0.05 as level of significance, at least 2 x 26 patients should be studied,
total of 52 patients. In order to adjust for missing data and protocol violations we decided
to include 2 x 30 patients in our study.
This is a study where all parties are blinded for the allocation. A study nurse draws up the
allocated study medication in an unmarked syringe so that the anesthesiologist is blinded.
The study nurse responsible for the medication is not the same nurse that does the
postoperative scoring. The study nurse responsible for the medication puts masked containers
of the allocated medication into opaque envelopes and delivers the envelope to the ward. The
ward personnel will then be masked for the allocation. The study nurse responsible for the
follow up calls are not the same study nurse responsible for the medications and as such is
also blinded for the allocation.
The primary outcome measure is the opiate consumption measured in oral morphine equivalents
after 1 hour.
Secondary outcome measures are;
- Opiate consummation after 4 hours, 24 hours, 48 hours and 7 days. As patients receive
different types of opiates, opiate consumption will be measured as oral morphine
equivalents for ease of comparison. Oksykodon iv is converted by a factor of 1:1,5 to
oral morphine.
- Time to first mobilization
- Time to first analgesic requirement
- Pain measuring tool used in this project is the validated numerical rating scale (NRS),
which is a 11- point scale from 0-10, where no pain is NRS=0, mild pain is NRS 1-3,
moderate pain NRS 4-6 and severe pain 7-10. NRS will be measured at rest and with
activity at the time points 1, 2 and 3 hours.
- Sedation is measured by the validated Pasero opioid-induced sedation scale (POSS). The
POSS measures normal sleep as S and then the degree of sedation on a numerical scale
from 1-4. Will be measured at 1, 2 and 3 hours.
- Nausea and vomiting is measured by the validated PONV impact scale. This is a tool that
entails two questions about nausea and vomiting, and each question gets rated on a
numeric scale from 0-4. Will be measured at 1, 2 and 3 hours.
After the operation the patients will be asked to answer the QoR-15, which consist of 15
questions distributed on two dimensions: "physical" and "mental" well-being, where the
patients report their experiences on a scale from 0 (=not at all) to 10 (=all the time). As a
complementing measure to the QoR-15 the patients will also be asked the EQ-5D questionnaire.
The EQ-5D questionnaire is an outcome measure of patient health after operation. The EQ-5D-5L
is comprised of two different measures; the EQ-5D descriptive system and the EQ visual
analogue scale (EQ VAS). Both QoR-15 and EQ-5D will be measured at 48 hours and 7 days.
The objective is to gain knowledge to support anesthesiologists when deciding analgesic
approach, as well as in shared decision-making with patients (including the patient
perspective). All results are expected to be presented during the project period.
